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FDA 510(k)

BARTELS CLOSTRIDIUM DIFFICILE TOXIN A ENZYM IMMUN

K-Number: K913229 · 1991-08-29

ApplicantBaxter Diagnostics, Inc.
Decision Date1991-08-29
Product CodeLLH
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

BARTELS CLOSTRIDIUM DIFFICILE TOXIN A ENZYM IMMUN is the device name listed in this FDA 510(k) record. The listed applicant is Baxter Diagnostics, Inc.. It received FDA 510(k) clearance on 1991-08-29 under 510(k) number K913229. The device is classified under product code LLH. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BARTELS CLOSTRIDIUM DIFFICILE TOXIN A ENZYM IMMUN?

BARTELS CLOSTRIDIUM DIFFICILE TOXIN A ENZYM IMMUN is a medical device that received FDA 510(k) clearance on 1991-08-29. The listed applicant is Baxter Diagnostics, Inc.. The 510(k) number is K913229.

When did BARTELS CLOSTRIDIUM DIFFICILE TOXIN A ENZYM IMMUN receive FDA 510(k) clearance?

BARTELS CLOSTRIDIUM DIFFICILE TOXIN A ENZYM IMMUN received FDA 510(k) clearance on 1991-08-29, under 510(k) number K913229.

Who is the listed applicant for BARTELS CLOSTRIDIUM DIFFICILE TOXIN A ENZYM IMMUN?

The FDA 510(k) record lists Baxter Diagnostics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BARTELS CLOSTRIDIUM DIFFICILE TOXIN A ENZYM IMMUN?

The FDA product code for BARTELS CLOSTRIDIUM DIFFICILE TOXIN A ENZYM IMMUN is LLH.

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Other records listing Baxter Diagnostics, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K934458DRIED GRAM-POSITIVE MIC/COMBO PANELSK950817DRIED GRAM POSITIVE MIC/COMBO PANELS/PNEUMOCOCCIK935704DRIED GRAM-NEGATIVE MIC//COMBO PANELSK950570STRATUS PROGESTERONE FLUOROMETRIC ENZYME IMMUNOASSAYK945235DRIED GRAM-POSITIVE MIC/COMBO PANELSK941030DRIED GRAM-NEGATIVE CEFPODOXIME

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Related Devices (Code: LLH)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K193490SensiTox C. difficile Toxin TestFirst Light Diagnostics, Inc.K102242OSOM C. DIFFICILE TOXIN A/B TESTGenzyme CorporationK091109XPERT C. DIFFICILECepheidK090239PROGASTRO CD ASSAYProdesse, Inc.K082499C. DIFF QUIK CHEK COMPLETETechlab, Inc.K081920BD GENEOHM CDIFF ASSAYBd Diagnostics (Geneohm Sciences, Inc.)

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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